Hereditary angioedema is already performing well, just two months after US approval.

Shire’s new immunology drug Takhzyro (lanedelumab-flyo) for the treatment of hereditary angioedema (HAE) was approved by the US Food and Drug Administration in late August, yet brought in $51 million in sales in the third quarter.

Takhzyro is seen as a best-in-class drug for HAE prophylaxis. It has IP protection to 2032, orphan drug status, a convenient dosing regimen and very strong efficacy data. Its main competition is CSL Behring’s Haegarda (C1Esterase Inhibitor Subcutaneous [Human]), which has a less favorable dosing regimen. 

According to Shire CEO Flemming Ornskov, both patients already receiving treatment and patients new to prophylaxis are switching to or selecting Takhzyro. The use so soon after approval may be due to Shire’s Quick Start program, which allows patients to start therapy before insurance companies have established the drug on their formularies. Ornskoy is “very positive” that getting reimbursement for Quick Start patients won’t be a problem.

Outside of the US, Shire is also expecting significant interest in Takhzyro.